NCT01682707

Brief Summary

Opioids provide greater patient comfort during intubation, but are not able to abolish completely the release adrenergic hormones during the laryngoscopy, which may cause undesirable hemodynamic changes. In this study the investigators selected two techniques commonly used for intubation, laryngoscopy and track light, so the investigators can verify which intubation techniques provides less hemodynamic changes in coronary patients under standard anesthesia induction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
Last Updated

September 11, 2012

Status Verified

April 1, 2012

Enrollment Period

28 days

First QC Date

April 1, 2010

Last Update Submit

September 10, 2012

Conditions

Keywords

intubationcoronary diseasehemodynamic responseanesthesia with tracheal intubationassessment of hemodynamic response

Outcome Measures

Primary Outcomes (1)

  • hemodynamic response

    tracheal intubation with track light release less adrenergic hormones than laryngoscopy intubation

    patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation

Study Arms (2)

Laryngoscopy

ACTIVE COMPARATOR

Laryngoscopy Track Light teaqueal intubation

Procedure: laryngoscopy

Track Light

ACTIVE COMPARATOR
Procedure: track light

Interventions

laryngoscopyPROCEDURE

tracheal intubation with two different techniques, track light and laryngoscopy.

Also known as: rigidy laryngoscopy,
Laryngoscopy
track lightPROCEDURE
Track Light

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary disease ASA 2 e 3 using beta-blockers

You may not qualify if:

  • emergency surgery arrythmia other antiarrythmic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology / Ministry of Health

Rio de Janeiro, Rio de Janeiro, 22240-005, Brazil

Location

Related Publications (3)

  • Nishiyama T, Misawa K, Yokoyama T, Hanaoka K. Effects of combining midazolam and barbiturate on the response to tracheal intubation: changes in autonomic nervous system. J Clin Anesth. 2002 Aug;14(5):344-8. doi: 10.1016/s0952-8180(02)00370-7.

    PMID: 12208438BACKGROUND
  • Nora FS, Klipel R, Ayala G, Oliveira Filho GR. [Remifentanil: does the infusion regimen make a difference in the prevention of hemodynamic responses to tracheal intubation?]. Rev Bras Anestesiol. 2007 Jun;57(3):247-60. doi: 10.1590/s0034-70942007000300003. Portuguese.

  • Almeida MC, Martins RS, Martins AL. [Tracheal intubation conditions at 60 seconds in children, adults and elderly patients.]. Rev Bras Anestesiol. 2004 Apr;54(2):204-11. doi: 10.1590/s0034-70942004000200007. Portuguese.

Related Links

MeSH Terms

Conditions

Coronary Disease

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Study Officials

  • Marcello F Salgado filho, MD

    Federal University of Juiz de Fora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

April 1, 2010

First Posted

September 11, 2012

Study Start

February 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 11, 2012

Record last verified: 2012-04

Locations